MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY FOL SIL 16FR 10ML W/UM MF

Catalog Number	DYND150816S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 there was "great difficulty" while attempting to inflate the balloon and "shortly after" the foley began to "leak".The customer reported after the incident occurred that the balloon was deflated "with great difficulty" and an additional catheter was inserted.The customer reported they did not pre-inflate the balloon prior to insertion, and the sterile water that was provided in the kit was used for balloon inflation.The customer did not report any serious injury related to the reported event.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2024 there was "great difficulty" while attempting to inflate the balloon and "shortly after" the foley began to "leak".

• Common Device Name: TRAY FOL SIL 16FR 10ML W/UM MF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20714610
• Report Number: 1417592-2024-00964
• Device Sequence Number: 8210836
• Product Code: OHR
• UDI-Device Identifier: 40195327149711
• UDI-Public: 40195327149711
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: DYND150816S
• Device Lot Number: 24GBC210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown